Abiomed (NASDAQ: ABMD) announces the results of PROTECT III, the ongoing, prospective, single-arm FDA post-approval study for the PMA approval of Impella 2.5 and Impella CP in high-risk PCI. PROTECT ...
NEW ORLEANS -- This weekend, catheter-based therapies have potentially practice-changing trial results expected at the American College of Cardiology (ACC) annual conference. Kicking off the opening ...
Routine use of the Impella CP microaxial flow pump did not improve outcomes and may have contributed to deaths among patients undergoing high-risk percutaneous coronary intervention (PCI), according ...
For Abiomed’s beleaguered family of Impella heart pumps, Class I recalls are becoming a monthly event. The devices have racked up their third recall in as many months, the latest of which focuses on ...
Abiomed has recalled the labeling for catheters used in its Impella RP Flex with Smart Assist System, the US Food and Drug Administration announced Thursday. The action comes from concern over a lack ...